Skip to main content
OpenTrials
Completed

NCT Number: NCT05661162

Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA)

Single arm clinical investigation, post-market confirmatory interventional to assess performance, safety and tolerability of "CR500 SINGLE-DOSE GEL" medical device in patients with knee osteoarthritis (KOA).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas

Castellanza, Varese, 21053, Italy

About this study

Subjects 26-83 years old will receive CR500 SINGLE-DOSE GEL given for the treatment of osteoarthritis of the knee over a 4-week time period. The primary objective of the study is to evaluate the effect of CR500 SINGLE-DOSE GEL in the treatment of KOA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female, aged ≥18 years at the time of the signature of ICF (Informed Consent Form).
  • Patients with a diagnosis of primary or secondary KOA affecting only one knee (monolateral KOA) of "mild" (score 1 - 4) or "moderate" (score 5 - 7) severity according to the LKI score.
  • Willing to follow all study procedures, including attending all site visits, tests and examinations.
  • Willing to participate in the study and sign the ICF.

Exclusion criteria

  • Osteoarthritis (OA) in both knees (bilateral KOA).
  • Other - different - clinical conditions of the knee.
  • Infective or inflammatory processes near the area of treatment.
  • Damaged skin in the area of treatment.
  • Ongoing cutaneous allergies.
  • Serious and chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy.
  • Allergy to device components (Sodium hyaluronate; Synthetic Human (SH)-Polypeptide-85; SH-Polypeptide-93; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; Polyethylene Glycol (PEG)-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA).
  • Any other systemic or local therapy for the treatment of KOA.
  • Any other systemic or local therapy (e.g. NSAIDs, corticosteroids) for the treatment of other inflammatory diseases (e.g. dermatitis, acute or chronic bronchitis, gastroenteritis, etc.) or painful states (e.g. headache, dental abscess, etc.) that may interfere with the clinical course of KOA under treatment with the medical device CR500.
  • Immune system illnesses.
  • Uncontrolled systemic diseases.
  • Known drug and/or alcohol abuse.
  • Mental incapacity that precludes adequate understanding or cooperation.
  • Participation in another investigational study.
  • Pregnancy* or breastfeeding.

Treatment and study plan

CR 500™ SINGLE-DOSE GEL

Device

CR 500™ SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, useful to attenuate the physiological degeneration of cartilage typical of osteoarthritic processes. The presence of sodium hyaluronate facilitates the movement of joints and tendons for greater mobility and flexibility

Primary outcomes

  1. OA evaluation, measured by Lequesne Knee Index (LKI)

    Time frame: 4 weeks

    The primary efficacy endpoint of the study will be the evaluation of the clinical performance of the CR 500™, used as intended in patients affected by KOA, in variation of symptoms related to the physiological degeneration of cartilage typical of osteoarthritic processes, in terms of difference in LKI score between the end study visit and baseline visit.

    Lequesne Knee Index Score:

    minimum index score: 0 maximum index score: 24

    0 means none OA

    >= means extremely severe OA

Secondary outcomes

  1. Lequesne Knee Index (LKI) Score

    Time frame: 4 weeks

    To evaluate the clinical performance of the CR 500™ across the study by Lequesne Knee Index (LKI) score.

    Lequesne Knee Index Score:

    minimum index score: 0 maximum index score: 24

    0 means none OA

    >= means extremely severe OA

  2. Lequesne Knee Index (LKI) Subscore

    Time frame: 4 weeks

    To evaluate the clinical performance of the CR 500™ by each Lequesne Knee Index (LKI) subscore

    Lequesne Knee Index Score:

    minimum index score: 0 maximum index score: 24

    0 means none OA

    >= means extremely severe OA

  3. Symptoms Variation in terms of Lequesne Knee Index (LKI) score

    Time frame: 4 weeks

    To evaluate the clinical performance of the CR 500™ in the attenuation of symptoms in patients affected by KOA stratified by KOA severity as assessed by Lequesne Knee Index (LKI) score

  4. Cluster of Subjective Symptoms evaluated by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

    Time frame: 4 weeks

    To evaluate the different dimensions of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

    Koos converted into a 0-100 Score

    0 means worst level of OA 100 means best level of OA

    Subscores:

    Pain, Symptoms, Sports, Quality of Life, Activities of Daily Living

  5. Number of participants with treatment-related adverse event as assessed by a questionnaire.

    Time frame: 4 weeks

    To evaluate the side effects of the product CR 500™ through a the completion of a specific questionnaire by the patient.

  6. Product tolerability and patient satisfaction as assessed by a questionnaire using a five-points Likert scale

    Time frame: 4 weeks

    To evaluate the tolerability and patient satisfaction of the CR 500™ through a the completion of a specific questionnaire by the patient, the five-points Likert scale in which 1 means Strongly disagree with the assertion and 5 means Strongly agree

  7. Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen (C2C)

    Time frame: 4 weeks

    Evaluation of the status of the cartilage degradation by quantification of neoepitope of type II collagen in synovial fluid by ELISA (ng/mL)

  8. Evaluation of the status of the cartilage degradation by quantification of C-terminal telopeptide of type II collagen (CTX-II)

    Time frame: 4 weeks

    Evaluation of the status of the cartilage degradation by quantification of C-terminal telopeptide of type II collagen quantification (CTX-II) in synovial fluid by ELISA (pg/mL)

  9. Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) quantification

    Time frame: 4 weeks

    Evaluation of the status of the cartilage by quantification of type II collagen propeptide (CPII) in synovial fluid by ELISA (ng/mL)

  10. Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) quantification

    Time frame: 4 weeks

    Evaluation of the status of the cartilage by quantification of hyaluronic acid (HA) in synovial fluid by ELISA (mg/mL)

  11. Evaluation of the inflammatory status of the knee joint by quantification of tumour necrosis factor (TNF) quantification

    Time frame: 4 weeks

    Evaluation of the status of the cartilage by quantification of tumour necrosis factor (TNF) in synovial fluid by ELISA (pg/mL)

  12. Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206)

    Time frame: 4 weeks

    Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 206 (CD206) by Real Time Polymerase Chain Reaction (PCR)

  13. Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c)

    Time frame: 4 weeks

    Evaluation of the macrophages infiltration in the knee joint by quantification of Cluster of Differentiation 11c (CD11c) by Real Time PCR

Sponsors and collaborators

Lead sponsor

Contrad Swiss SA

Industry

Registry information

Official study title

Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA): a Post-market Confirmatory Interventional, Single Arm Clinical Investigation

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2022
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.